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FDA Announces Sunscreen Labeling Changes to Better Inform Consumers (June 2011)

New guidelines for sunscreen product labels give consumers more information to help reduce the risk of skin cancer and early aging.

On June 14, the U.S. Food and Drug Administration (FDA) announced that sunscreen products meeting modern standards of effectiveness may include new labeling information to help consumers find products that help prevent sun related health hazards.

The final rule permits sunscreen products that pass FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) to be labeled as “Broad Spectrum.” Although sunburn is caused primarily by UVB rays, both UVA and UVB radiation contribute to sunburn, skin cancer and premature skin aging. Under the new labeling requirements, sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent these risks.

Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass FDA testing criteria, however products cannot state on their label that they also prevent skin cancer, sunburn or premature aging unless they contain an SPF of 15 or higher.

If a product of SPF 2 to SPF 14 does not contain Broad Spectrum protection it will be required to include a warning on the label stating that the product has not been shown to prevent skin cancer or early skin aging.

Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research, explained that “Most skin cancers are caused by sun exposure, FDA encourages consumers to protect themselves. Not only should consumers regularly apply and reapply sunscreens with Broad Spectrum and SPF 15 or higher, they should also limit sun exposure.”

In addition to these new regulations, FDA also issued three supplemental regulatory documents; a Proposed Rule, an Advance Notice of Proposed Rulemaking (ANPR) for Dosage Forms, and a Draft Enforcement Guidance for Industry.

The proposed rule would limit the maximum SPF value on sunscreen labels to “50+” because there has not been sufficient data showing that SPF values over 50 are able to provide greater sun protection than SPF 50 products. This proposal opens the possibility for submission of data to support including higher SPF values in the final rule; FDA is accepting public comments on this document.
The ANPR will give the public a window of time to submit data addressing the effectiveness and the safety of sunscreen sprays and to comment on possible directions and warnings for sprays that FDA may pursue in the future, among other issues regarding dosage forms for sunscreens.

The Draft Enforcement Guidance for Industry outlines information to help sunscreen product manufacturers understand how to label and test their products in light of the new final rule and other regulatory initiatives.

To ensure that sunscreen products meet modern safety standards, FDA is also currently reexamining the safety information available for active ingredients included in sunscreens on the market today.  However, these ingredients have been used for many years and FDA does not have any reason to believe that these products are not safe for consumer use.

The new regulations will become effective in one year; however, manufacturers with annual sales less than $25,000 have two years to comply.

For more information, please Contact TSG.
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